Free samples of medicines

Article 125 – Free samples

(Legislative Decree No. 219, April 24, 2006)

1. Free samples of a medicine for human use can only be given to doctors authorized to prescribe it and must be delivered only through scientific representatives. Physicians must ensure storage according to the instructions indicated on the package or on the package leaflet.
2. Samples cannot be delivered without a written request bearing the recipient's date, stamp and signature.
3. Scientific reps can give each healthcare professional two samples per visit for each dosage or pharmaceutical form of a medicinal product exclusively in the eighteen months following the date of first marketing of the product and within the maximum limit of eight samples per year for each dosage or form.
4. Without prejudice to the provisions of paragraph 2, scientific representatives can also deliver to the doctor no more than four samples per visit, within the maximum limit of ten samples per year, chosen from the company list of medicines on the market for more than eighteen months.
5. The quantitative limits of paragraphs 3 and 4 also apply to medicines that can be sold to the public in pharmacies and are not dispensed at the expense of the National Health Service.
6. Each sample must be graphically identical to the smallest package on the market. Its content may be lower, in number of dosage units or in volume, than that of the package on the market, provided it is therapeutically suitable; the non-correspondence of the content and, possibly, of the primary packaging to the authorized package must be expressly referred to on the label.
7. The summary of product characteristics must always be delivered together with the samples, except in the case provided for by paragraph 5 of article 122.
8. Except in the case of obvious technical difficulties, the external packaging, the primary packaging and, if necessary, the self-adhesive sticker used for the dispensing of the medicinal product at the expense of the National Health Service, must bear the indelible indication "free sample - prohibited for sale" or other similar expression.
9. No sample of the medicinal products governed by the consolidated text referred to in decree of the President of the Republic 9 October 1990, n. 309.
10. Pharmaceutical companies are required to ensure that any storage conditions indicated on the external packaging or on the primary packaging of the medicinal product are respected until the sample is delivered to the doctor. In particular, companies will have to provide their scientific representatives with all the necessary information relating to the methods of correct conservation and distribution of medicines envisaged by current legislation, equipping them with the appropriate stowage tools for free samples for their transport. Scientific reps must be given free samples in quantities proportional to the number of visits scheduled for a given period, generally every fifteen days.

(Amended by article 2, paragraph 24 of legislative decree 274/07 – Ed.)

11. The delivery of samples to the hospital doctor is subject to the provisions of this article.
12. Pharmaceutical companies are required to withdraw from the scientific informants any medical request referred to in paragraph 2 and keep, for eighteen months, suitable documentation to prove that the delivery of samples took place in compliance with the provisions of this decree.
13. The Minister of Health, on the proposal of AIFA, taking into account the trend in the consumption of medicines, may, by decree, reduce the number of samples that can be delivered by scientific representatives pursuant to this article or provide for specific further limitations for certain categories of medicines.

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